BICORE SMARTCATH INTRATRACHEAL CATHETER

Accessory To Continuous Ventilator (respirator)

BICORE MONITORING SYSTEMS

The following data is part of a premarket notification filed by Bicore Monitoring Systems with the FDA for Bicore Smartcath Intratracheal Catheter.

Pre-market Notification Details

Device IDK935788
510k NumberK935788
Device Name:BICORE SMARTCATH INTRATRACHEAL CATHETER
ClassificationAccessory To Continuous Ventilator (respirator)
Applicant BICORE MONITORING SYSTEMS 2-A FARADAY Irvine,  CA  92718
ContactMuir S Meinhold
CorrespondentMuir S Meinhold
BICORE MONITORING SYSTEMS 2-A FARADAY Irvine,  CA  92718
Product CodeMOD  
CFR Regulation Number868.5895 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-12-06
Decision Date1995-07-03

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